T-Cell and NK-Cell Neoplasm Clinical Trial
Official title:
Integration of Machine Learning and Genomics to Predict Outcomes for Newly Diagnosed, Relapsed and Refractory Mature T-cell and NK/T-cell Lymphomas: a Global Study of the PETAL Consortium
The goal of this observational study is to correlate molecular alterations with outcomes including overall survival (OS), progression-free survival (PFS) for patients with a new diagnosis, primary refractory or relapse, of mature T-cell and NK-cell neoplasms (TNKL). We hypothesize that machine learning will uncover distinct genetic vulnerabilties that underlie treatment response and resistance for patient with TNKL.
This study is a prospective longitudinal observational study of newly diagnosed and relapsed/refractory patients with T-cell and NK -cell neoplasm at participating institutions. Patients will be enrolled in the study during the course of their first visit as a new patient at the participating institution and followed for up to 4 years through the course of their clinical management. Routine demographics, baseline clinical features, including pathology, molecular information related to the tumor, radiology, treatment characteristics and quality of life (QoL) related to their lymphoma care will be collected over the course of 4 years by clinical research teams at every participating institution. This data will be de-identified data and then shared through a secure and password protected REDCap with other participating institutions under data usage agreements of the consortium agreement. Next generation sequencing including but not limited to such as whole exome sequencing and bulk RNA-sequencing will be performed on archived lymphoma specimens and on mononuclear cells, cfDNA and saliva (when feasible) for detailed molecular characterization of the tumor. Molecular correlation with outcomes will be performed. Deep learning algorithms will be utilized to predict response and survival of lymphoma subtypes and in heterogeneous clinical scenarios and to various potential therapeutic approaches that the patient has not been exposed to. ;